Ethical requirements for occupational health research : compliance arrangements for a single company in relation to a recent major nuclear industry study.

The media coverage given to occupational health studies in the field of ionizing radiation has, on occasion, been the cause of very real distress to radiation workers and their families.

In response to this situation the Chief Medical Officers of the major UK nuclear companies developed an ethical policy for future involvement in research, based on the duty of care which researchers owe to a key customer of such studies : the worker.

The policy consists of four principal elements :

medical confidentiality ;

worker information ;

worker consent and the guarantee of the availability to the workers of pre-publication knowledge of the results.

The policy issued in 1991/92 has achieved growing acceptance among researchers and medical journals, though the medical officers involved have been aware of some scepticism, particularly in relation to the practicalities of the dissemination of pre-publication information.

The Record Linkage Study published in November 1997 marked a major piece of research work involving data from 120,000 radiation workers that had been carried out since the development of the policy.

This paper reports on the successful compliance arrangements to meet the ethical requirements of that study within a single UK nuclear company, and is published to demonstrate that with commitment from researchers, the journal and occupational health staff such ethical requirements, and particularly the need for pre-publication information can be met in full.